Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis
ConditionDiabetic Ketoacidosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe George Institute
About this trial
The goal of this blinded, cluster cross-over, randomised controlled trial is to determine whether fluid therapy with Plasma-Lyte® 148 increases the number of days alive and days out of hospital to day-28 compared to 0.9% sodium chloride ('0.9% saline') in critically ill patients presenting to the Emergency Department (ED) and deemed to require admission to a critical care area (ICU, HDU) with moderate to severe diabetic ketoacidosis (DKA).
Eligibility criteria
Qualifiers
Patients in the ED with a primary diagnosis of moderate to severe DKA for whom both saline and Plasma-Lyte® 148 are considered appropriate fluids
Blood glucose level > 14mmol/L
pH < 7.25
Serum bicarbonate <15 mmol/L
Disqualifiers
Age less than 18 years
Patients who have received more than 2000ml of non study fluid prior to study enrolment
Serum Na > 155 or <120 mmol/L
Contraindication to either study fluid e.g. previous allergic reaction to Plasma-Lyte® 148
Trial design
Treatments tested in this trial
- Plasma-Lyte 148
- 0.9% sodium chloride
Treatment groups
680 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov